Ambulatory Blood Pressure Monitoring in Oral Testosterone... | NCT03868059

Status Module

Label	Type	Description	Intervention Names
LPCN 1021	Experimental	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),	Drug: LPCN 1021

Name	Type	Description	Arm Group Labels	Other Names
LPCN 1021	Drug	LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.	LPCN 1021

Measure	Description	Time Frame
Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)	Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)	Baseline to end of study (approximately 4 months).

Measure	Description	Time Frame
Change in ABPM-measured Average Daytime SBP	Change in average daytime SBP as measured by ABPM from Visit 3 to Visit 5	Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Nighttime SBP

Measure	Description	Time Frame
Change is SBP Dip	Change in systolic blood pressure dip, as defined as the difference between daytime mean systolic blood pressure and nighttime mean systolic blood pressure, from Visit 3 to Visit 5	Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65.
Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
Serum total T below lab normal range (300 ng/dL) based on two consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate washout of current androgen replacement therapy, if required.
Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility.
Judged to be in good general health as determined by the investigator at screening.

Exclusion Criteria:

History of significant sensitivity or allergy to androgens, or product excipients.
Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
1. Hemoglobin < 11.5 g/dL or > 16.5 g/dL
2. Hematocrit < 35% or > 54%
3. Serum transaminases > 2.5 times upper limit of normal
4. Serum bilirubin > 2.0 mg/dL
5. Creatinine > 2.0 mg/dL
6. PSA > 4 ng/mL
7. Prolactin > 17.7 ng/mL.
Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
Subjects with screening systolic BP or diastolic BP above 160 mmHg or 100 mmHg, respectively.
Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
History of seizures or convulsions occurring after age 5, including alcohol or drug withdrawal seizures.
History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
Known tolerability issues with ABPM devices.
History of stroke, myocardial infarction, transient ischemic attack, or acute coronary syndrome within the past 5 years.
History of long QT syndrome (or QTcB > 450) or unexplained sudden death (including cardiac death) or history of long QT syndrome in a first degree relative (parent, sibling, or child).
Subjects who are not on stable dose of current medication (no changes in medication in the last 3 months).
History of current or suspected prostate or breast cancer.
History of untreated obstructive sleep apnea or not compliant with sleep apnea treatment.
Active alcohol or any drug substance abuse, or history of abuse that will interfere with the subject's ability to participate in the study in the judgement of the investigator.
Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study. A list of prohibited medications is provided in Appendix C.
Use of any investigational drug within 5 half-lives of the last dose in the past 6 months prior to Study Day -2 without principal investigator and/or sponsor approval.
Receipt of any investigational drug by injection within 30 days or 10 half-lives (whichever is longer) prior to study drug administration without principal investigator and/or sponsor approval.
Subject who is not willing to use adequate contraception for the duration of the study.
Any contraindications to a MRI scan (i.e. subjects with non-removable ferromagnetic implants, pacemakers, aneurysm clips or other foreign bodies), and/or subjects with claustrophobic symptoms and/or inability to fit into an MRI scanner.
Inability to understand and provide written informed consent for the study.
Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive LPCN 1021 (exact reason should be specified by the investigator).

Name	Affiliation	Role
Anthony Delconte, MD	Lipocine Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Clinical Therapeutics		Birmingham	Alabama	35235	United States
South Florida Medical Research

PubMed Identifier	Type	Citation	Retractions
34191621	Derived	White WB, Dobs A, Carson C, DelConte A, Khera M, Miner M, Shahid M, Kim K, Chidambaram N. Effects of a Novel Oral Testosterone Undecanoate on Ambulatory Blood Pressure in Hypogonadal Men. J Cardiovasc Pharmacol Ther. 2021 Nov;26(6):630-637. doi: 10.1177/10742484211027394. Epub 2021 Jun 30.

ID	Title	Description
FG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 19, 2019	Apr 1, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)

Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)

Subjects who had evaluable average 24-hour SBP measurements from Baseline to End of Study

Posted

Mean

Standard Deviation

mmHg

Baseline to end of study (approximately 4 months).

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000118

Title

Denominators

Categories

Title	Measurements
	OG0003.8± 11.8

Secondary

Change in ABPM-measured Average Daytime SBP

Change in average daytime SBP as measured by ABPM from Visit 3 to Visit 5

Subjects who had evaluable average daytime SBP measurements from Baseline to End of Study

Posted

Mean

Standard Deviation

mmHg

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Change in ABPM-measured Average Nighttime SBP

Change in average nighttime SBP as measured by ABPM from Visit 3 to Visit 5

Subjects with evaluable average nighttime SBP measurements from Baseline to End of Study

Posted

Mean

Standard Deviation

mmHg

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)

Change in average 24-hour DBP as measured by ABPM from Visit 3 to Visit 5

Subjects with evaluable average 24-hour DBP measurements from Baseline to End of Study

Posted

Mean

Standard Deviation

mmHg

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Change in ABPM-measured Average Daytime DBP

Change in average daytime DBP as measured by ABPM from Visit 3 to Visit 5

Subjects who had evaluable average daytime DBP measurements from Baseline to End of Study

Posted

Mean

Standard Deviation

mmHg

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Change in ABPM-measured Average Nighttime DBP

Change in average nighttime DBP as measured by ABPM from Visit 3 to Visit 5

Subjects who had evaluable average nighttime DBP measurements from Baseline to End of Study

Posted

Mean

Standard Deviation

mmHg

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Change in ABPM-measured Average 24-hour Pulse Rate (PR)

Change in average 24-hour pulse rate as measured by ABPM from Visit 3 to Visit 5

Subjects who had evaluable average 24-hour PR measurements from Baseline to End of Study

Posted

Mean

Standard Deviation

bpm

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Change in ABPM-measured Average Daytime PR

Change in average daytime pulse rate as measured by ABPM from Visit 3 to Visit 5

Subjects who had evaluable average daytime PR measurements from Baseline to End of Study

Posted

Mean

Standard Deviation

bpm

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Change in ABPM-measured Average Nighttime PR

Change in average nighttime pulse rate as measured by ABPM from Visit 3 to Visit 5

Subjects who had evaluable average nighttime PR measurements from Baseline to End of Study

Posted

Mean

Standard Deviation

bpm

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Change in Morning SBP Measured in Triplicate at the Clinic

Change in morning systolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5

Subjects who had evaluable morning SBP measurements in triplicate at the clinic at Baseline and end of Study

Posted

Mean

Standard Deviation

mmHg

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Change in Morning DBP Measured in Triplicate at the Clinic

Change in morning diastolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5

Subjects who had evaluable morning DBP measurements in triplicate at the clinic at Baseline and end of Study

Posted

Mean

Standard Deviation

mmHg

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Change in Morning PR Measured in Triplicate at the Clinic

Change in morning pulse rate measured in triplicate at the clinic from Visit 3 to Visit 5

Subjects who had evaluable morning PR measurements in triplicate at the clinic at Baseline and End of Study

Posted

Mean

Standard Deviation

bpm

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Change in Patient Reported Sexual Distress

Change in patient reported sexual distress from visit 3 to Visit 5 Female Sexual Distress Scale - Revised, Item 13 Possible scores range from 0 (better) to 4 (worse)

Subjects with evaluable patient reported sexual distress questionnaire responses

Posted

Mean

Standard Deviation

units on a scale

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Change in Patient Reported Sexual Desire

Change in patient reported sexual desire from visit 3 to Visit 5 Psychosexual Daily Questionnaire Possible scores range from 0 (worse) to 5 (better)

Subjects with evaluable patient reported sexual desire questionnaire responses

Posted

Mean

Standard Deviation

units on a scale

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5%

Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥5%

Subjects with evaluable baseline and interim MRI-PDFF data, with MRI-PDFF measurement of ≥5% at baseline

Posted

Mean

Standard Deviation

% Relative Change

Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5%

Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥5%

Subjects with evaluable baseline and post-treatment MRI-PDFF data, with MRI-PDFF measurement of ≥5% at baseline

Posted

Mean

Standard Deviation

% Relative Change

Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%

Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥10%

Subjects with evaluable baseline and interim MRI-PDFF data, with MRI-PDFF measurement of ≥10% at baseline

Posted

Mean

Standard Deviation

% Relative Change

Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Secondary

Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%

Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥10%

Subjects with evaluable baseline and post-treatment MRI-PDFF data, with MRI-PDFF measurement of ≥10% at baseline

Posted

Mean

Standard Deviation

% Relative Change

Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Other Pre-specified

Change is SBP Dip

Change in systolic blood pressure dip, as defined as the difference between daytime mean systolic blood pressure and nighttime mean systolic blood pressure, from Visit 3 to Visit 5

Subjects who had evaluable SBP dip measurements from Baseline to End of Study

Posted

Mean

Standard Deviation

mmHg

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Other Pre-specified

Change in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS)

Change in average 24-hour SBP in subjects with a low cardiovascular risk based on their Framingham Risk Score (0\

Subjects with a low FRS (0\

Posted

Mean

Standard Deviation

mmHg

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Other Pre-specified

Change in ABPM-measured Average 24-hour SBP in Subjects With a Moderate Framingham Risk Score (FRS)

Change in average 24-hour SBP in subjects with a moderate cardiovascular risk based on their Framingham Risk Score (11≤FRS<24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\

Subjects with a medium FRS (11≤FRS<24) who had evaluable 24-hour SBP measurements from baseline to end of study

Posted

Mean

Standard Deviation

mmHg

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Other Pre-specified

Change in ABPM-measured Average 24-hour SBP in Subjects With a High Framingham Risk Score (FRS)

Change in average 24-hour SBP in subjects with a high cardiovascular risk based on their Framingham Risk Score (FRS≥24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\

Subjects with a high FRS (FRS≥24) who had evaluable 24-hour SBP measurements from baseline to end of study

Posted

Mean

Standard Deviation

mmHg

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Other Pre-specified

Change in ABPM-measured Average 24-hour SBP in Subjects With a Baseline SBP >140mmHg

Change in average 24-hour SBP as measured by ABPM in subjects with a baseline SBP >140mmHg from Visit 3 to Visit 5

Subjects with a baseline SBP >140mmHg who had evaluable average 24-hour SBP measurements from baseline to end of study

Posted

Mean

Standard Deviation

mmHg

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Other Pre-specified

Change in Hematocrit From Baseline

Change in Hematocrit (%) from Visit 3 to Visit 5

Subjects with evaluable Hematocrit values from baseline and end of study

Posted

Mean

Standard Deviation

percentage of hematocrit

Baseline to end of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Other Pre-specified

Number of Participants Who Started a New Hypertensive Medication or Increased Their Hypertensive Medication Dose

Number of participants who had to start a new hypertensive medication or increase their hypertensive medication dose from Visit 3 to Visit 5

Posted

Count of Participants

Participants

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Other Pre-specified

Change in Hemoglobin From Baseline

Change in Hemoglobin from Visit 3 to Visit 5

Subjects with evaluable Hemoglobin values from baseline and end of study

Posted

Mean

Standard Deviation

g/dL

Baseline to End of Study (approximately 4 months)

ID	Title	Description
OG000	LPCN 1021	LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Units	Counts
Participants	OG000

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Psychiatric Disorders	Psychiatric disorders	MedDRA (17.1)	Systematic Assessment	Schizoaffective Disorder Bipolar Type	EG0001 affected138 at risk
Musculoskeletal and Connective Tissue Disorders	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Systematic Assessment	Arthritis	EG0001 affected138 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Polycythemia	Blood and lymphatic system disorders	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected138 at risk
Hypertension	Vascular disorders	MedDRA (17.1)	Systematic Assessment	EG0007 events6 affected138 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected138 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected138 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected138 at risk
Dizziness	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected138 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0005 events5 affected138 at risk
Sinusitis	Infections and infestations	MedDRA (17.1)	Systematic Assessment	EG0002 events2 affected138 at risk
Haematocrit increased	Investigations	MedDRA (17.1)	Systematic Assessment	EG0004 events4 affected138 at risk

ID	Term
D007006	Hypogonadism
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

ID	Term
D013739	Testosterone
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D045165	Testosterone Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists